Cervicogenic HeadachesNCT02070172
Active and Passive Cervical Flexion-rotation Tests
An observational study of Cervicogenic Headaches, run by Des Moines University at 1 site in United States.
Trial summary
Motion limitations have been previously reported in people with headaches originating from the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been found useful to diagnose this type of headache. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicogenic Headaches
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: two groups of subjects were included; those with cervicogenic headaches and an asymptomatic group of healthy volunteers
Who may be able to join
- One-sided headaches
- Headaches caused by neck movement or sustained head positioning
- Neck, shoulder, or arm pain
- Intermittent headaches at least one headache per week for greater than 2 months
- Headaches of moderate intensity
Who cannot join
- A diagnosis of rheumatoid arthritis
- Current pregnancy
- International Headache Society criteria for other headache forms (such as tension or migraine)
- Cervical radiculopathy
- Treatment for headaches by a physical therapist, chiropractor, massage therapist, or osteopath in the past month
- Positive test for vertebral artery insufficiency or cranial-vertebral ligament instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Range of Motion During the Active and Passive Flexion-rotation Tests in Subjects Patients With Cervicogenic Headache
Motion limitations have been previously reported in people with headaches originating from the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been found useful to diagnose this type of headache. This observational study investigates this neck motion test when performed actively by the patient and passively by the examiner, then compares the results of motion attained.
- Conditions
- Cervicogenic Headaches
- Keywords
- headache diagnosis, flexion rotation test, range of motion, upper cervical
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cervicogenic Headache Group | This group of subjects is considered the symptomatic group. No intervention was provided in this study so there are no intervention groups. | |
| Healthy, Asymptomatic Group | Subjects in this group had no headache symptoms. Their neck motion was compared to subjects in the headache group. No intervention was provided to subjects in either group for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Range of Motion in degrees with the Flexion Rotation Test
Two versions of this test were examined. A motion analysis system was used to measure degrees of motion. The test was done in two ways on each subject. Subjects sat in a chair, looked downward, then rotated their head/neck each direction. Subjects laid on their back while an examiner lifted their head, then rotated it each direction (same motion as described for the active test in the previous sentence).
Within session reliability was also examined.
Measured: Baseline only
Secondary outcomes (1)
Northwick park neck disability index
This self-report questionnaire was completed by subjects prior to testing. It was not re-assessed as an outcome but rather used for baseline description of the subjects included in the study.
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Des Moines University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Petersen, Des Moines University
- Investigators
- Shannon Petersen, PT, DScPT, Principal investigator, Des Moines University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070172
- Sponsor's protocol ID
- DMUSP2
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Range of Motion During the Active and Passive Flexion-rotation Tests in Subjects Patients With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT02070172
- Acronym / sponsor ID
- DMUSP2
- Conditions
- Cervicogenic Headaches
- Keywords
- headache diagnosis, flexion rotation test, range of motion, upper cervical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Des Moines UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Motion limitations have been previously reported in people with headaches originating from the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been found useful to diagnose this type of headache. This observational study investigates this neck motion test when performed actively by the patient and passively by the examiner, then compares the results of motion attained.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervicogenic Headache Group | – | –This group of subjects is considered the symptomatic group. No intervention was provided in this study so there are no intervention groups. |
| Healthy, Asymptomatic Group | – | –Subjects in this group had no headache symptoms. Their neck motion was compared to subjects in the headache group. No intervention was provided to subjects in either group for this study. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- two groups of subjects were included; those with cervicogenic headaches and an asymptomatic group of healthy volunteers
Key inclusion criteria (5 listed)
- One-sided headaches
- Headaches caused by neck movement or sustained head positioning
- Neck, shoulder, or arm pain
- Intermittent headaches at least one headache per week for greater than 2 months
- Headaches of moderate intensity
Key exclusion criteria (6 listed)
- A diagnosis of rheumatoid arthritis
- Current pregnancy
- International Headache Society criteria for other headache forms (such as tension or migraine)
- Cervical radiculopathy
- Treatment for headaches by a physical therapist, chiropractor, massage therapist, or osteopath in the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cervical Range of Motion in degrees with the Flexion Rotation Test
Time frame: Baseline only
Two versions of this test were examined. A motion analysis system was used to measure degrees of motion. The test was done in two ways on each subject. Subjects sat in a chair, looked downward, then rotated their head/neck each direction. Subjects laid on their back while an examiner lifted their head, then rotated it each direction (same motion as described for the active test in the previous sentence). Within session reliability was also examined.
1 secondary outcome
Northwick park neck disability index
Time frame: Baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Petersen, PT, DScPT principal investigator
Des Moines University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervicogenic Headaches, run by Des Moines University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Range of Motion in degrees with the Flexion Rotation Test (time frame: Baseline only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.